AtriCure Treats First Patient in LeAAPS Clinical Trial

AtriCure, a company specializing in surgical treatments and therapies for atrial fibrillation (AFib), left atrial appendage (LAA) management, and post-op pain management, announced the first patient was treated in the company’s Left Atrial Appendage Exclusion for Stroke Prevention (LeAAPS) clinical trial.
 
The patient was treated by U.S. co-principal investigator Dr. Marc Gerdisch at Franciscan St. Francis Heart Center in Indianapolis, Ind.
 
LeAAPS is an investigational device exemption (IDE) trial to assess the AtriClip LAA exclusion system’s safety and effectiveness to prevent ischemic stroke or systemic arterial embolism in cardiac surgery patients at higher risk for those events and with no history of AFib. The trial will enroll up to 6,500 patients at 250 centers globally.
 
LeAAPS aims to inform and better define clinical practice and treatment guidelines for stroke prevention in patients undergoing planned cardiac surgery with an elevated risk of ischemic stroke and systemic embolism.
 
“The LeAAPS trial is a landmark study to evaluate the prophylactic use of AtriClip devices for stroke reduction in cardiac surgery patients without a preoperative Afib diagnosis, laying the groundwork for a new frontier in stroke prevention,” Michael Carrel, president and CEO of AtriCure told the press. “We have an impressive roster of world-class physicians and hospitals that will be enrolling patients, and we see a substantial opportunity to leverage the AtriClip platform for better long-term outcomes in this patient population while expanding our markets.”
 
AtriClip received 510(k) clearance in 2010. Today, according to the company, AtriClip system products are the most widely used LAA management devices worldwide. AtriCure intends to use the trial results to expand labeled indications of the AtriClip system to include stroke prevention in patients with higher risk of ischemic stroke events.
 
The trial will be completed in collaboration with the Population Health Research Institute (PHRI), which is associated with McMaster University in Hamilton, Ontario.
 
“LeAAPS is one the largest randomized controlled trials in cardiac device history, and we expect it will establish a new standard of care for patients undergoing cardiac surgery,” said Dr. Richard Whitlock, Cardiothoracic Surgeon, McMaster University, and Global Principal Investigator for the trial. “A fantastic multidisciplinary team has designed the trial, and we’re all excited to advance the understanding of atrial disease, atrial fibrillation and stroke.”